A Randomized, Double Blind, Double-dummy, 2-treatment, 2-period Crossover Comparison of Sennosides and Polyethylene Glycol in Treatment of Opioid-induced Constipation in Outpatients With Cancer
18 Years
N/A
Both
Constipation, Cancer
Trial Information
A Randomized, Double Blind, Double-dummy, 2-treatment, 2-period Crossover Comparison of Sennosides and Polyethylene Glycol in Treatment of Opioid-induced Constipation in Outpatients With Cancer
One group will be started on a bowel protocol of escalating doses of sennosides, plus a
dummy polyethylene glycol (lactose), and the other will receive dummy sennosides capsules
(lactose)plus polyethylene glycol, with the same dosing protocol. After three weeks the
patients will switch to the alternate active product and dummy preparation. The total
duration for the study will be 6 weeks for each patient.
Inclusion Criteria:
1. Adult patient (18 years and above) with diagnosis of cancer.
2. Patient has constipation defined as BPS (Bowel Performance Score) -2 or less.
3. Patient is able to communicate effectively with staff.
4. Expected prognosis more than 12 weeks.
5. On opioid therapy with daily dose range no more than 30% of minimum daily consumption
over previous 7 days.
6. Patients may be included if they have previously been taking laxatives but are still
constipated (BPS -2 or less).
Exclusion Criteria:
1. Patient unable to take oral medication.
2. New treatment expected to affect bowel function during the study (6 weeks), e.g.
opioid rotation, commencement of drug with laxative/constipating effect, such as
misoprostol, ondansetron etc.
3. Allergy or previous intolerance to PEG or sennosides.
4. Lactose intolerant.
5. Contraindication to PEG or sennosides.
6. Known or suspected bowel obstruction or ileus.
7. Colostomy or ileostomy.
8. Inflammatory bowel disease.
9. Hospitalisation expected within the study period.
10. Patient unable to complete the study diary in English.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Bowel Performance Scale (BPS)
Outcome Description:
The proportion of days in which the BPS is within the range -1 to +1 wll be compared between treatment periods
Outcome Time Frame:
Last 18 days of each 21 day study period
Safety Issue:
No
Principal Investigator
Philippa Hawley, FRCPC
Investigator Role:
Principal Investigator
Investigator Affiliation:
British Columbia Cancer Agency
Authority:
Canada: Health Canada
Study ID:
H0901329
NCT ID:
NCT01189409
Start Date:
June 2010
Completion Date:
Related Keywords:
- Constipation
- Cancer
- Constipation
- Opioids
- Cancer
- Polyethylene glycol
- Sennosides
- Opioid Therapy
- Constipation
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